NCT00492466

Brief Summary

This study is to find out if Interferon-beta can recover its effectiveness in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
Last Updated

January 30, 2008

Status Verified

January 1, 2008

Enrollment Period

3.4 years

First QC Date

June 25, 2007

Last Update Submit

January 28, 2008

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Multiple SclerosisantibodyNeutralizing antibodyBinding antibodyMxA protein

Outcome Measures

Primary Outcomes (1)

  • Reduction in the proportion of patients being neutralizing antibody (NAb) positive (titre>20)

    Month -1 and after 3, 6, 9, 12, and 15 months

Secondary Outcomes (5)

  • Change in MxA protein values

    Month -1 and after 3, 6, 9, 12, and 15 months

  • Change in binding antibody (Bab) tires

    Month -1 and after 3, 6, 9, 12, and 15 months

  • Proportion of patients with NAb positive titre <5

    Month -1 and after 3, 6, 9, 12, and 15 months

  • Change in annualised relapse rate

    at 3, 6, 9, 12, and 15 months

  • The number of relapse-free patients

    at 3, 6, 9, 12, and 15 months

Study Arms (1)

1

EXPERIMENTAL
Drug: Interferon-beta-1aDrug: methylprednisolone

Interventions

Interferon-beta-1aDRUG

dosage and frequency as per label

Also known as: Avonex
1
methylprednisoloneDRUG

dosage and frequency as per Biogen Idec protocol

1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Relapsing remitting Multiple Sclerosis according to Poser criteria (CDMS or LDMS) or Multiple Sclerosis according to McDonald criteria
  • Disability equivalent to EDSS of 6.0 or less
  • Clinical activity defined as at least one relapse rate within the last 12 months
  • NAb titre \>20 (measured at least 48 hours after last interferon-beta injection
  • has been treated with subcutaneously administered interferon-beta-1b or interferon-beta-1a (Rebif) for at least 24 hours before enrollment

You may not qualify if:

  • Any condition that might give rise to similar symptoms as MS
  • History of major depression
  • Alcohol or drug dependency
  • Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
  • hypertension (BP \> 180/110 mmHg)
  • Renal insufficiency defined as serum creatinine \> 1.5 times the upper normal reference limit
  • Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
  • Gastro-intestinal ulcers, gastritis, or dyspepsia
  • Women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. To avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coordinating Research Site

Turku, Finland

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

Interferon beta-1aMethylprednisolone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Biogen-Idec Investigator

    neurologyclinicaltrials@biogenidec.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 27, 2007

Study Start

March 1, 2003

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

January 30, 2008

Record last verified: 2008-01

Locations

FI(1)